Recalling Firm / Manufacturer

Abbott Diagnostic International, Ltd

Product

IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent.

Code Information

46810Q100, 49118Q100, 49555Q100

Reason of Recall

An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy

Date Recall Initiated

April 10, 2007

Action

The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.